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HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Healthy Weight Coaching
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring eHealth, web-based, internet-based, digital, body weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age over 18 years
  • body mass index (BMI) ≥ 25 kg/ m²
  • the possibility to use a computer and /or a smartphone with access to the internet
  • willingness to participate in the digital treatment program

Exclusion Criteria:

  • diagnosed severe illness requiring assessment from the specialty care obesity center
  • pregnancy or breastfeeding

Sites / Locations

  • University of HelsinkiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Healthy Weight Coaching

Arm Description

Intervention: Healthy Weight Coaching.

Outcomes

Primary Outcome Measures

% weight loss
Mean weight change in %

Secondary Outcome Measures

Categorical weight loss
% patients achieving 3-4.9%, 5-9.9% and >10% weight loss
Sleep
Self-reported sleep variables are measured by a questionnaire that was modified from the Basic Nordic Sleep Questionnaire and The National FINRISK study. Included are questions about sleep duration, chronotype, tiredness, sleep apnoea, and medication.
Health-Related Quality of Life
Health-related quality of life is measured by the RAND36 questionnaire.
Psychological Flexibility
Psychological flexibility is assessed by the Acceptance and Action Questionnaire for Weight (AAQW). It is a 22-item, Likert-type scale that measures acceptance of weight related thoughts and feelings with valued actions.
Eating behaviour
Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.

Full Information

First Posted
July 12, 2019
Last Updated
March 17, 2022
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04019249
Brief Title
HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting
Official Title
HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 31, 2030 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates the effectiveness of a web-based obesity management program HealthyWeightCoaching (HWC), within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland.
Detailed Description
Obesity is one of the major public health problems globally and it increases the risk of many obesity-associated diseases. Treatment of obesity requires long-term interventions, but nevertheless, it is challenging to provide long-term treatment when resources in real-life health care systems are limited. New cost-effective and accessible intervention methods are needed. The modern treatment of obesity is based on behavioral changes that modify one´s daily lifestyle, which, according to recent research, are effective especially in the prevention of diabetes. However, little is known about the utilization and effectiveness of online programs using novel interactive technologies. The aim of this study is to evaluate the effectiveness of a real-life web-based obesity management program (HealthyWeightCoaching, HWC) on weight loss, health, quality of life, and factors predicting long term success in treating overweight adult patients. Healthy Weight Coaching is a novel 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. The program is structured around weekly exercise modules. In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland. The program is free for the patient to use. The 12-month intervention is followed by a 5-year monitoring period. Questionnaires on health, quality of life, and lifestyle are collected at 0, 3, 6, 9, and 12-month time points. Body weight is collected by weekly logs. The recruitment is ongoing as the program is currently used in clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
eHealth, web-based, internet-based, digital, body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Healthy Weight Coaching
Arm Type
Experimental
Arm Description
Intervention: Healthy Weight Coaching.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Weight Coaching
Intervention Description
Healthy Weight Coaching is a 52 week long web-based weight loss program consisting of weekly modules, exercises, peer support, and one-on-one coaching. It encompasses themes such as diet, physical activity, coping with stress, sleep, and general health.
Primary Outcome Measure Information:
Title
% weight loss
Description
Mean weight change in %
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Categorical weight loss
Description
% patients achieving 3-4.9%, 5-9.9% and >10% weight loss
Time Frame
baseline to 12 months
Title
Sleep
Description
Self-reported sleep variables are measured by a questionnaire that was modified from the Basic Nordic Sleep Questionnaire and The National FINRISK study. Included are questions about sleep duration, chronotype, tiredness, sleep apnoea, and medication.
Time Frame
baseline to 12 months
Title
Health-Related Quality of Life
Description
Health-related quality of life is measured by the RAND36 questionnaire.
Time Frame
baseline to 12 months
Title
Psychological Flexibility
Description
Psychological flexibility is assessed by the Acceptance and Action Questionnaire for Weight (AAQW). It is a 22-item, Likert-type scale that measures acceptance of weight related thoughts and feelings with valued actions.
Time Frame
baseline to 12 months
Title
Eating behaviour
Description
Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.
Time Frame
baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age over 18 years body mass index (BMI) ≥ 25 kg/ m² the possibility to use a computer and /or a smartphone with access to the internet willingness to participate in the digital treatment program Exclusion Criteria: diagnosed severe illness requiring assessment from the specialty care obesity center pregnancy or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsi Pietiläinen, MD-PhD
Phone
+358505992295
Email
kirsi.pietilainen@helsinki.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi Pietiläinen, MD-PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsi Pietiläinen
Phone
+358505992295
Email
kirsi.pietilainen@helsinki.fi

12. IPD Sharing Statement

Citations:
PubMed Identifier
32885090
Citation
Suojanen LU, Ahola AJ, Kupila S, Korpela R, Pietilainen KH. Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Contemp Clin Trials Commun. 2020 Aug 13;19:100638. doi: 10.1016/j.conctc.2020.100638. eCollection 2020 Sep.
Results Reference
derived
Links:
URL
https://www.terveyskyla.fi/painonhallinta
Description
The HealthyWeightHub portal, into which the HealthyWeightCoaching program is embedded (in Finnish and Swedish only)

Learn more about this trial

HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting

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